CN102085344A - Aplotaxis carminative sustained-release preparation and preparation method thereof - Google Patents
Aplotaxis carminative sustained-release preparation and preparation method thereof Download PDFInfo
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- CN102085344A CN102085344A CN 201010622177 CN201010622177A CN102085344A CN 102085344 A CN102085344 A CN 102085344A CN 201010622177 CN201010622177 CN 201010622177 CN 201010622177 A CN201010622177 A CN 201010622177A CN 102085344 A CN102085344 A CN 102085344A
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Abstract
The invention relates to an aplotaxis carminative sustained-release preparation and a preparation method thereof. The preparation method comprises the following steps: according to the traditional proportion, preparing aplotaxis, amomum fruit, vinegared rhizoma cyperi, Areca catechu, licorice root, dried orange peel, Mangnolia officinalis, stir-fried fructus aurantii, stir-fried rhizoma atractylodis, stir-fried green tangerine orange peel and ginger into an aplotaxis carminative medicine extract; and preparing 5-50 parts of aplotaxis carminative medicine extract, 10-200 parts of filler, 10-100 parts of sustained-release material, 0-30 parts of disintegrant, 0-10 parts of lubricant, 0-10 parts of flow aid and 10-200 parts of hot-melt extrusion auxiliary material into the aplotaxis carminative sustained-release preparation by using a conventional preparation technique or hot-melt extrusion preparation technique. The aplotaxis carminative sustained-release preparation provided by the invention has the advantages of unique technique, high stability and stable and long-lasting preparation release, and can be continuously and stably released in vivo for 12 hours, so that the active pharmaceutical ingredients can last in vivo for a long time and can be absorbed continuously by human bodies, thereby achieving the goal of long-acting.
Description
Technical field
The invention belongs to the Chinese medicine preparation technical field, relate to novel form of Chinese medicine aplotaxis carminative pill and preparation method thereof, particularly relate to pleasant slow releasing preparation of a kind of Radix Aucklandiae and preparation method thereof.
Background technology
Functional dyspepsia is more common disease, and how slow onset is, and the course of disease is very long, normal persistence or outbreak repeatedly.The conventional formulation aplotaxis carminative pill is made up of ten Herba indigoferae Pseudotinctoriae such as the Radix Aucklandiae, Fructus Amomi, Rhizoma Cyperi (vinegar system), Semen Arecae, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis (system), Fructus Aurantii (parched), Rhizoma Atractylodis (stir-fry), Pericarpium Citri Reticulatae Viride (stir-fry), Rhizoma Zingiberiss, has the circulation of qi promoting removing dampness, the effect of invigorating the spleen and regulating the stomach, be used for clinically that chest and diaphragm painful abdominal mass due to the turbid damp retardance mechanism of qi is vexed, abdominal distention, vomiting are felt sick, belch is indigestion and loss of appetite, and be better for the functional dyspepsia therapeutic effect.
The pleasant patent medicine of the present Radix Aucklandiae mainly is honeyed pill, the watered pill or granule, there is certain defective in such preparation: the pill taking dose is big, the patient is difficult for swallowing, and the molten diffusing speed of disintegrate is slow, the evenly stripping of the active component of various character, short at gastric transit time, can't be directly in the diseased region release, thereby cause its bioavailability low, influence curative effect of medication; The granule sugar content is higher, and easily moisture absorption caking influences product quality, and is not suitable for middle-aged and elderly people and diabetics is taken.
Therefore, active component evenly discharges in the pleasant patent medicine of the Radix Aucklandiae to develop a kind of new can making, and directly acts on diseased region for a long time, and the novel formulation that improves bioavailability is very important.Slow releasing preparation in the Western medicine just in time can reach above specification requirement.Yet those of ordinary skills know that the slow releasing preparation of Chinese medicine is obviously different with the Western medicine slow releasing preparation, Western medicine slow releasing preparation content composition is more single, be easy to make, and prescriptions of Chinese medicine is very complicated, paste-forming rate is big, water absorption is strong, the content preparation is comparatively complicated, and this just requires Chinese medicine slow releasing preparation content not only uniform and stable, but also will have good flowability, therefore, it is very big to make good effect, biological utilisation power height, stay-in-grade Chinese medicine slow releasing preparation technical difficulty.
Summary of the invention
The purpose of this invention is to provide pleasant slow releasing preparation of a kind of Radix Aucklandiae and preparation method thereof, to solve the problem that exists in the existing pleasant conventional formulation of the Radix Aucklandiae.
Technical scheme of the present invention is: add hot melt and extrude pharmaceutic adjuvant and other necessary pharmaceutic adjuvants in the pleasant prescription medicine extract of traditional Radix Aucklandiae, adopt conventional formulation technology or hot melt to extrude preparation process and be processed into the pleasant slow releasing preparation of the Radix Aucklandiae, described slow releasing preparation is tablet, capsule or micropill.
The pleasant slow releasing preparation of the Radix Aucklandiae of the present invention is to be prepared from by pleasant prescription medicine extract of the Radix Aucklandiae of following weight proportioning and adjuvant:
5～50 parts of the pleasant prescription medicine extracts of the Radix Aucklandiae, 10～200 parts of filleies, 10～100 parts of slow-release materials, 0～30 part of disintegrating agent, 0～10 part of lubricant, 0～10 part of fluidizer, hot melt are extruded 10～200 parts of adjuvants.
Wherein, the pleasant prescription medicine extract of the described Radix Aucklandiae is to be constituent with the Radix Aucklandiae, Fructus Amomi, Rhizoma Cyperi (processed with vinegar), Semen Arecae, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Sichuan Cortex Magnoliae Officinalis (processed), Fructus Aurantii (parched), Rhizoma Atractylodis (parched), parch skin, Rhizoma Zingiberis Recens, the water extract of the prescription medicine of forming according to traditional ratio.
Described filler is one or more in microcrystalline Cellulose, mannitol, lactose, the amylum pregelatinisatum; Described slow-release material is one or more in ethyl cellulose, acrylic resin, ethylene-vinyl acetate copolymer, hydroxypropyl cellulose, cellulose acetate, hypromellose, methylcellulose, polyvidone, sodium alginate, the chitin; Described disintegrating agent is one or more in crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, microcrystalline Cellulose, the sodium alginate; Described lubricant, fluidizer are one or more in Pulvis Talci, micropowder silica gel, hydrogenated vegetable oil, Polyethylene Glycol, stearic acid, magnesium stearate, the dicalcium phosphate dihydrate; It is polyvinylpyrrolidone that described hot melt is extruded adjuvant.
The weight proportion of pleasant prescription medicine extract of the comparatively ideal Radix Aucklandiae of the present invention and adjuvant is:
10～30 parts of the pleasant prescription medicine extracts of the Radix Aucklandiae, 40～100 parts of filleies, 20～50 parts of slow-release materials, 5～20 parts of crospolyvinylpyrrolidone, 0～5 part of micropowder silica gel, 0～5 part of magnesium stearate, hot melt are extruded 20～100 parts of adjuvants.
Further, the optimum weight proportioning of pleasant prescription medicine extract of the Radix Aucklandiae of the present invention and adjuvant is:
20 parts of the pleasant prescription extract of Radix Aucklandiae extracts, 80 parts of filleies, 30 parts of slow-release materials, 80 parts of polyvinylpyrrolidones, 10 parts of disintegrating agents, 2 parts of micropowder silica gels, 2 parts of magnesium stearate.
The concrete preparation method of the pleasant slow releasing preparation of the Radix Aucklandiae of the present invention is:
1), the pleasant prescription medicine extract of the preparation Radix Aucklandiae: get 100 parts of the Radix Aucklandiae, 100 parts of Fructus Amomis, 100 parts of Rhizoma Cyperi (processed with vinegar), 100 parts of Semen Arecaes, 100 parts of Pericarpium Citri Reticulataes, 100 parts of Sichuan Cortex Magnoliae Officinalis (processed), 100 parts of Fructus Aurantii (parched), 100 parts of Rhizoma Atractylodis (parched), 100 parts of parch skins, 200 parts of merging of Rhizoma Zingiberis Recens, the water that adds 10 times of weight of medicine, distillating extracting oil 5 hours, it is standby to collect volatile oil; Extracting liquid filtering, it is standby to get filtrate A; Medicinal residues merge with 50 portions of Radix Glycyrrhizaes again, add 80%～85% ethanol of 8 times of weight, and reflux, extract, 2 hours filters, and it is standby that filtrate is concentrated into fluid extract A; The decocting that medicinal residues add 10 times of weight again boils once, filters, and it is standby to get liquor B; Merging filtrate A, liquor B are condensed into fluid extract B, and with after above-mentioned fluid extract A mixes, drying under reduced pressure becomes dry extract, sprays into above-mentioned volatile oil and obtains the pleasant prescription medicine extract of the Radix Aucklandiae again.
2), the preparation Radix Aucklandiae pleasant slow releasing preparation: get 10～30 parts of the pleasant prescription medicine extracts of the above-mentioned Radix Aucklandiae, 40～100 parts of filleies, 20～50 parts of slow-release materials, hot melt and extrude 20～100 parts of adjuvants, 5～20 parts of crospolyvinylpyrrolidone, 0～5 part of micropowder silica gel, 0～5 part of magnesium stearate, after crossing 40～200 mesh sieves respectively, with extract and each adjuvant by the recipe quantity equivalent mix homogeneously that progressively increases, be prepared into the pharmaceutically active intermediate by the hot melt extruding technology, survey intermediate content, adopt the conventional formulation method to be prepared into tablet, capsule or pellet preparations again.
Compared with the prior art, the present invention is on the prescription basis of original aplotaxis carminative pill, through testing repeatedly, contrast, conclude, screening, summary has obtained the pleasant slow releasing preparation of a kind of brand-new Radix Aucklandiae, this slow releasing preparation technology uniqueness, good stability, preparation discharges stable lasting, sustainable in vivo stable release 12 hours makes active constituents of medicine continue for a long time in vivo to be absorbed by human body, has reached long lasting purpose.The pleasant slow releasing preparation of the Radix Aucklandiae of the present invention is not only additional perfect to existing dosage form, and has enriched the kind of dosage form, for the utilization of Banksia rose preparation for lowering adverse Qi flow clinically provides a kind of new selection.
Description of drawings
Fig. 1 is the release in vitro of the pleasant slow releasing preparation of the Radix Aucklandiae of the present invention line of writing music.
The specific embodiment
Embodiment 1
The pleasant slow releasing tablet of the preparation Radix Aucklandiae
Prescription: 20 parts of the pleasant prescription medicine extracts of the Radix Aucklandiae, 20 parts of hypromelloses (HPMC), 100 parts of polyvinylpyrrolidones (Kollidon), 10 parts of crospolyvinylpyrrolidone, 2 parts of micropowder silica gels, 2 parts of magnesium stearate.
Technology: get 20 parts of extracts, Kollidon100 part, HPMC20 part and cross 100 mesh sieves, standby; Be prepared into intermediate by the hot melt extrusion method, detect intermediate content, standby; Intermediate is pulverized, and adds 10 parts of crospolyvinylpyrrolidone, 2 parts of micropowder silica gels, 2 parts of magnesium stearate, mix homogeneously, and tabletting, promptly.
Embodiment 2
The pleasant slow releasing tablet of the preparation Radix Aucklandiae
Prescription: 20 parts of the pleasant prescription medicine extracts of the Radix Aucklandiae, 30 parts of hypromelloses (HPMC), 80 parts of polyvinylpyrrolidones (Kollidon), 10 parts of crospolyvinylpyrrolidone, 2 parts of micropowder silica gels, 2 parts of magnesium stearate.
Technology: get 20 parts of extracts, Kollidon80 part, HPMC30 part and cross 100 mesh sieves, standby; Be prepared into intermediate by the hot melt extrusion method, detect intermediate content, standby; Intermediate is pulverized, and adds 10 parts of crospolyvinylpyrrolidone, 2 parts of micropowder silica gels, 2 parts of magnesium stearate, mix homogeneously, and tabletting, promptly.
Embodiment 3
The pleasant slow releasing capsule of the preparation Radix Aucklandiae
Prescription: 20 parts of the pleasant prescription medicine extracts of the Radix Aucklandiae, Kollidon80 part, HPMC30 part, 10 parts of crospolyvinylpyrrolidone, 2 parts of micropowder silica gels, 2 parts of magnesium stearate.
Technology: get 20 parts of extracts, Kollidon80 part, HPMC30 part, 10 parts of mistake 100 mesh sieves of crospolyvinylpyrrolidone, standby; Be prepared into intermediate by the hot melt extrusion method, detect intermediate content, standby; Intermediate is pulverized, and adds 2 parts of micropowder silica gels, 2 parts of magnesium stearate, and mix homogeneously is encapsulated, promptly.
Embodiment 4
The pleasant slow-release micro-pill of the preparation Radix Aucklandiae
Prescription: 20 parts of the pleasant prescription medicine extracts of the Radix Aucklandiae, Kollidon100 part, HPMC20 part, 10 parts of crospolyvinylpyrrolidone, an amount of, the blank microsphere of coating material are an amount of.
Technology: get 20 parts of extracts, Kollidon100 part, HPMC20 part, 10 parts of mistake 100 mesh sieves of crospolyvinylpyrrolidone, standby; Be prepared into intermediate by the hot melt extrusion method, detect intermediate content, standby; Intermediate is pulverized, and be distributed in the coating solution and behind the mix homogeneously blank microsphere carried out coating, drying, packing, promptly.
Application examples
Medicine of the present invention is through release in vitro degree verification experimental verification, and its result of the test can reach the regulation of 2010 editions slow releasing preparation of Chinese Pharmacopoeia.
The pleasant slow releasing preparation release in vitro of table 1 Radix Aucklandiae degree result of the test
By table 1 data as can be seen, the sustainable in vivo stable release of this product is 12 hours.
Medicine of the present invention and ordinary preparation are carried out release in vitro degree contrast test, its result such as table 2 and Fig. 1:
The pleasant slow releasing preparation release in vitro of table 2 Radix Aucklandiae degree comparative test result
| 0h | 0.5h | 1h | 2h | 4h | 8h | 12h | |
| Aplotaxis carminative pill | 0.00％ | 64.00％ | 98.50％ | --- | --- | --- | --- |
| Embodiment 1 | 0.00％ | 6.10％ | 14.78％ | 21.50％ | 39.60％ | 68.70％ | 95.40％ |
| Embodiment 2 | 0.00％ | 7.20％ | 18.94％ | 24.30％ | 41.30％ | 73.20％ | 98.20％ |
| Embodiment 3 | 0.00％ | 5.80％ | 16.71％ | 22.80％ | 40.28％ | 70.15％ | 94.30％ |
| Embodiment 4 | 0.00％ | 8.60％ | 20.10％ | 25.40％ | 43.50％ | 76.80％ | 97.70％ |
By the experimental result of table 2 and Fig. 1 as can be seen, the pleasant slow releasing preparation of the Radix Aucklandiae is compared with ordinary preparation, can stablize the release that continues in vivo, thereby prolonged the action time of medicine, and the blood concentration fluctuation of minimizing because of frequently taking medicine and causing, improved curative effect, increased the safety of medicine.
Certainly, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill and the customary means of this area.
More than be that form by embodiment is described in further detail content of the present invention, but this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to above specific embodiment, all technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
Claims (9)
1. pleasant slow releasing preparation of the Radix Aucklandiae is to be prepared from by pleasant prescription medicine extract of the Radix Aucklandiae of following weight proportioning and adjuvant:
5～50 parts of the pleasant prescription medicine extracts of the Radix Aucklandiae, 10～200 parts of filleies, 10～100 parts of slow-release materials, 0～30 part of disintegrating agent, 0～10 part of lubricant, 0～10 part of fluidizer, hot melt are extruded 10～200 parts of adjuvants;
Wherein, the pleasant prescription medicine extract of the described Radix Aucklandiae is to be constituent with the Radix Aucklandiae, Fructus Amomi, Rhizoma Cyperi (processed with vinegar), Semen Arecae, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Sichuan Cortex Magnoliae Officinalis (processed), Fructus Aurantii (parched), Rhizoma Atractylodis (parched), parch skin, Rhizoma Zingiberis Recens, the water extract of the prescription medicine of forming according to traditional ratio.
2. the pleasant slow releasing preparation of the Radix Aucklandiae according to claim 1 is characterized in that described filler is one or more in microcrystalline Cellulose, mannitol, lactose, the amylum pregelatinisatum.
3. the pleasant slow releasing preparation of the Radix Aucklandiae according to claim 1 is characterized in that described slow-release material is one or more in ethyl cellulose, acrylic resin, ethylene-vinyl acetate copolymer, hydroxypropyl cellulose, cellulose acetate, hypromellose, methylcellulose, polyvidone, sodium alginate, the chitin.
4. the pleasant slow releasing preparation of the Radix Aucklandiae according to claim 1 is characterized in that described disintegrating agent is one or more in crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, microcrystalline Cellulose, the sodium alginate.
5. the pleasant slow releasing preparation of the Radix Aucklandiae according to claim 1 is characterized in that described lubricant, fluidizer are one or more in Pulvis Talci, micropowder silica gel, hydrogenated vegetable oil, Polyethylene Glycol, stearic acid, magnesium stearate, the dicalcium phosphate dihydrate.
6. the pleasant slow releasing preparation of the Radix Aucklandiae according to claim 1 is characterized in that it is polyvinylpyrrolidone that described hot melt is extruded adjuvant.
7. the pleasant slow releasing preparation of the described Radix Aucklandiae according to claim 1 is characterized in that being prepared from by pleasant prescription medicine extract of the Radix Aucklandiae of following weight proportioning and adjuvant:
10～30 parts of the pleasant prescription medicine extracts of the Radix Aucklandiae, 40～100 parts of filleies, 20～50 parts of slow-release materials, 5～20 parts of crospolyvinylpyrrolidone, 0～5 part of micropowder silica gel, 0～5 part of magnesium stearate, hot melt are extruded 20～100 parts of adjuvants.
8. the pleasant slow releasing preparation of the described Radix Aucklandiae according to claim 1 is characterized in that being prepared from by pleasant prescription medicine extract of the Radix Aucklandiae of following weight proportioning and adjuvant:
20 parts of the pleasant prescription extract of Radix Aucklandiae extracts, 80 parts of filleies, 30 parts of slow-release materials, 80 parts of polyvinylpyrrolidones, 10 parts of disintegrating agents, 2 parts of micropowder silica gels, 2 parts of magnesium stearate.
9. the preparation method of the pleasant slow releasing preparation of the described Radix Aucklandiae of claim 7 may further comprise the steps:
1), the pleasant prescription medicine extract of the preparation Radix Aucklandiae: get 100 parts of the Radix Aucklandiae, 100 parts of Fructus Amomis, 100 parts of Rhizoma Cyperi (processed with vinegar), 100 parts of Semen Arecaes, 100 parts of Pericarpium Citri Reticulataes, 100 parts of Sichuan Cortex Magnoliae Officinalis (processed), 100 parts of Fructus Aurantii (parched), 100 parts of Rhizoma Atractylodis (parched), 100 parts of parch skins, 200 parts of merging of Rhizoma Zingiberis Recens, the water that adds 10 times of weight of medicine, distillating extracting oil 5 hours, it is standby to collect volatile oil; Extracting liquid filtering, it is standby to get filtrate A; Medicinal residues merge with 50 portions of Radix Glycyrrhizaes again, add 80%～85% ethanol of 8 times of weight, and reflux, extract, 2 hours filters, and it is standby that filtrate is concentrated into fluid extract A; The decocting that medicinal residues add 10 times of weight again boils once, filters, and it is standby to get liquor B; Merging filtrate A, liquor B are condensed into fluid extract B, and with after above-mentioned fluid extract A mixes, drying under reduced pressure becomes dry extract, sprays into above-mentioned volatile oil and obtains the pleasant prescription medicine extract of the Radix Aucklandiae again;
2), the preparation Radix Aucklandiae pleasant slow releasing preparation: get 10～30 parts of the pleasant prescription medicine extracts of the above-mentioned Radix Aucklandiae, 40～100 parts of filleies, 20～50 parts of slow-release materials, hot melt and extrude 20～100 parts of adjuvants, 5～20 parts of crospolyvinylpyrrolidone, 0～5 part of micropowder silica gel, 0～5 part of magnesium stearate, after crossing 40～200 mesh sieves respectively, with extract and each adjuvant by the recipe quantity equivalent mix homogeneously that progressively increases, be prepared into the pharmaceutically active intermediate by the hot melt extruding technology, survey intermediate content, adopt the conventional formulation method to be prepared into tablet, capsule or pellet preparations again.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102671100A (en) * | 2012-05-14 | 2012-09-19 | 李承平 | Medicinal composition for regulating qi and promoting blood circulation |
| CN103479782A (en) * | 2013-08-30 | 2014-01-01 | 贵阳新天药业股份有限公司 | Slow-release capsule and preparation method thereof |
| JP2018533654A (en) * | 2015-10-23 | 2018-11-15 | ビーエーエスエフ ソシエタス・ヨーロピアＢａｓｆ Ｓｅ | Solid solution of odorant and flavor substances with vinyl lactam polymer |
| CN111494464A (en) * | 2020-05-21 | 2020-08-07 | 北京紫云腾中药饮片有限公司 | Processed nux vomica and processing technology and application thereof |
| CN112755068A (en) * | 2021-02-25 | 2021-05-07 | 河南省济源市济世药业有限公司 | Stable compound rabdosia rubescens preparation and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102671100A (en) * | 2012-05-14 | 2012-09-19 | 李承平 | Medicinal composition for regulating qi and promoting blood circulation |
| CN103479782A (en) * | 2013-08-30 | 2014-01-01 | 贵阳新天药业股份有限公司 | Slow-release capsule and preparation method thereof |
| CN103479782B (en) * | 2013-08-30 | 2015-10-07 | 贵阳新天药业股份有限公司 | A kind of slow releasing capsule and preparation method thereof |
| JP2018533654A (en) * | 2015-10-23 | 2018-11-15 | ビーエーエスエフ ソシエタス・ヨーロピアＢａｓｆ Ｓｅ | Solid solution of odorant and flavor substances with vinyl lactam polymer |
| US11993759B2 (en) | 2015-10-23 | 2024-05-28 | Basf Se | Solid solutions of odoriferous substances and flavoring agents with vinyl lactam polymers |
| CN111494464A (en) * | 2020-05-21 | 2020-08-07 | 北京紫云腾中药饮片有限公司 | Processed nux vomica and processing technology and application thereof |
| CN111494464B (en) * | 2020-05-21 | 2021-11-26 | 北京紫云腾中药饮片有限公司 | Processed nux vomica and processing technology and application thereof |
| CN112755068A (en) * | 2021-02-25 | 2021-05-07 | 河南省济源市济世药业有限公司 | Stable compound rabdosia rubescens preparation and preparation method thereof |
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|---|---|
| CN102085344B (en) | 2012-10-17 |
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